Expandable Cardiac Mapping Frame for Precise Catheter Ablation
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Solution Overview
Problem
Intravascular or percutaneous medical devices face challenges in deployment, positioning, and operation due to the complexity of catheter systems and lack of direct visual contact, particularly in procedures like atrial fibrillation treatment, where creating lesions in correct cardiac locations is difficult.
Innovation Solution
A medical device with elongate members that can transition from an unexpanded configuration for catheter delivery to an expanded configuration for precise positioning, using transducer elements to discriminate between tissue and blood, and facilitate ablation, while allowing mapping and ablation without mechanical scanning.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If intravascular or percutaneous techniques are used to treat atrial fibrillation, then patient recovery time and surgery risk are reduced, but device complexity and difficulty in positioning increase
Solution Approach 1:
The medical device employs a nested structure where the expandable frame is delivered within a catheter system through a stenotomy incision. The frame transitions from a compressed delivery configuration to an expanded treatment configuration, allowing complex functionality to be delivered through a minimally invasive access point.
Solution Approach 2:
The device divides the treatment function into separate components: the expandable frame structure, the transducer elements for tissue discrimination, and the ablation capability. This segmentation allows each component to be optimized independently while being delivered as an integrated system.
2Reliability
If intravascular or percutaneous techniques are used to treat atrial fibrillation, then patient recovery time and surgery risk are reduced, but positioning accuracy and operational difficulty increase
Solution Approach 1:
The device incorporates transducer elements that provide real-time feedback by discriminating between cardiac tissue and blood. This feedback mechanism allows the operator to precisely determine the position and orientation of the device relative to cardiac features, ensuring accurate lesion placement.
Solution Approach 2:
The device replaces mechanical scanning systems with a stationary array of transducer elements that electronically discriminate tissue from blood. This substitution eliminates the complexity of mechanical scanning while maintaining or improving positioning accuracy.
3Measurement precision
If transducer elements are used to discriminate between tissue and blood, then lesion placement accuracy is improved, but device complexity increases
Solution Approach 1:
The transducer elements serve multiple functions: they discriminate between cardiac tissue and blood, provide positioning information, and potentially deliver ablation energy. This multi-functionality reduces the need for separate systems while maintaining high measurement precision.
Solution Approach 2:
The device merges the tissue discrimination function, positioning function, and ablation function into a single integrated system. The transducer elements are embedded within the expandable frame, combining sensing and treatment capabilities in one device structure.
4Object-affected harmful factors
If the device is designed for catheter delivery through bodily openings, then invasiveness is reduced, but the size of treatment elements is constrained
Solution Approach 1:
The device employs a dynamic structure that transitions from a compressed delivery configuration to an expanded treatment configuration. The expandable frame allows the treatment elements to achieve a larger effective area once deployed, while maintaining a small delivery profile for minimally invasive access.
Solution Approach 2:
The device nests the expandable frame and treatment elements within the catheter delivery system. The frame transitions from a compressed state during delivery to an expanded state during treatment, allowing large treatment elements to be delivered through small access points.
Applied Scientific Principles
This section explains which scientific principles are used to turn an abstract innovation direction into a practical engineering solution.
Function Achieved in This Case
Enhances the ability to accurately position and treat cardiac tissue by enabling precise lesion creation relative to anatomical features like pulmonary veins and mitral valves, improving treatment efficacy and reducing procedural complexity.
Implementation Method 1
The device can discriminate between fluid within the cavity (e.g., blood) and tissue that forms an inner or interior surface of the cavity to provide information or mapping indicative of a position or orientation
Implementation Method 2
Such lesions were originally created using incisions, but are now typically created by ablating the tissue with various techniques including radio frequency (RF) energy
Implementation Method 3
ablating the tissue with various techniques including radio frequency (RF) energy, microwave energy, laser energy and cryogenic techniques
Data Source
AI summary
Systems, methods, and devices allow intravascular or percutaneous mapping, orientation and/or ablation, in bodily cavities or lumens. A device includes elongate members, moveable between an unexpanded configuration and an expanded or fanned configuration. The elongate members form a stack in the unexpanded configuration to fit through a catheter sheath. The elongate members follow respective arcuate or curvilinear paths as advanced from the sheath into the bent or coiled stack configuration, adopting volute, scroll or rho shapes, and may be nested. The elongated members are fanned or radially spaced circumferentially with respect to one another into the expanded or fanned configuration. Transducer elements carried by elongate members sense various physiological characteristics of or proximate tissue, and/or may apply energy to or proximate tissue. The elongate members are rotatable in groups or as a group in the expanded configuration. The device is retractable.